Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia - Full Text View

Sponsor:	Cornea and Laser Eye Institute
Information provided by (Responsible Party):	Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier:	NCT01112072

Purpose

This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in keratoconus. This study will attempt to determine the relative efficacy of the two procedures either performed at the same session versus CXL performed 3 months after Intacs.

Condition	Intervention	Phase
Keratoconus Corneal Ectasia	Drug: Riboflavin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of Keratoconus and Corneal Ectasia

Resource links provided by NLM:

MedlinePlus related topics: Corneal Disorders

Drug Information available for: Riboflavin

U.S. FDA Resources

Further study details as provided by Cornea and Laser Eye Institute:

Primary Outcome Measures:

Maximum keratometry [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best Corrected Visual Acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intacs combined with CXL Intacs placement followed by collagen crosslinking with UV light and riboflavin	Drug: Riboflavin Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL. Other Names: Intracorneal Ring Segments Cornea Collagen Crosslinking
Active Comparator: Intacs followed by CXL Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later	Drug: Riboflavin Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL. Other Names: Intracorneal Ring Segments Cornea Collagen Crosslinking

Arms

Assigned Interventions

Active Comparator: Intacs combined with CXL

Intacs placement followed by collagen crosslinking with UV light and riboflavin

Drug: Riboflavin

Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL.

Other Names:

Intracorneal Ring Segments
Cornea Collagen Crosslinking

Active Comparator: Intacs followed by CXL

Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later

Drug: Riboflavin

Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL.

Other Names:

Intracorneal Ring Segments
Cornea Collagen Crosslinking

Detailed Description:

The purpose of this is to ascertain the possible additive effect of the two treatments to both improve the quality of the corneal optics (i.e. improve corneal topography regularity) and to stabilize the cornea. Previous investigations have shown that Intacs surgery, indeed, does improve corneal topography and improve contact lens tolerance and spectacle corrected visual acuity, as well as uncorrected visual acuity in some patients. Investigations of CXL have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this suggests a potential additive effect of the two on the patient's ultimate visual outcome. Thus, the patient would be afforded two potential benefits: (1) the potential of a more robust visual outcome and (2) stabilization of the keratoconic cornea on the longer term.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

21 years of age or older
Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)
Subjects who meet the manufacturer's nomogram recommendations for Intacs segments
Topography consistent with keratoconus or post-surgical corneal ectasia.
BSCVA worse than 20/20 (<55 letters on ETDRS chart)

Exclusion Criteria:

Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns when the hypotonic riboflavin us used, provided that the corneal thickness after treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry ≤ 450 microns at the proposed insertion site for the Intacs
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
History of corneal disease
History of chemical injury or delayed epithelial healing in the eye(s) to be treated.
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Subjects with nystagmus or any other condition that would prevent a steady gaze during the CXL and Intacs treatment or other diagnostic tests.
Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112072

Locations

United States, New Jersey
Cornea and Laser Eye Institute	Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Stacey Lazar 201-883-0505 info@vision-institute.com
Principal Investigator: Peter Hersh, M.D.

Sponsors and Collaborators

Cornea and Laser Eye Institute

Investigators

Principal Investigator:

Peter Hersh, M.D.

Cornea and Laser Eye Institute

More Information

No publications provided

Responsible Party:	Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier:	NCT01112072 History of Changes
Other Study ID Numbers:	CLEI-Intacs-CXL
Study First Received:	April 26, 2010
Last Updated:	September 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cornea and Laser Eye Institute:

keratoconus
corneal ectasia
collagen crosslinking

riboflavin
cornea
ultraviolet

Additional relevant MeSH terms:

Dilatation, Pathologic
Keratoconus
Corneal Diseases
Pathological Conditions, Anatomical
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents

Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012